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AbbVie Reconsiders Shire Offer

October 15, 2014

AbbVie sends Shire notice that it is reconsidering its offer recommendation.

ISPE Releases its Drug Shortages Prevention Plan

October 15, 2014

The International Society for Pharmaceutical Engineering (ISPE) released its Drug Shortages Prevention Plan as part of an initiative to address drug shortage prevention due to manufacturing and quality issues.

Change is Afoot at CPhI

October 8, 2014

New investments, expansions, and company rebranding are discussed at CPhI.

Meet this year's CPhI Pharma Awards Winners

October 7, 2014

Celebrating the best of pharma and recognizing companies that turn inspiration into innovation.

FDA Releases Q&A on DQSA

October 7, 2014

FDA releases question and answer draft guidance on drug product tracing and licensing requirements.

FDA Releases Guidance on Critical Path Innovation Meetings

October 7, 2014

FDA outlines procedures for having a Critical Path Innovation Meeting with CDER.

Hospira's Australian Manufacturing Plant Receives FDA Warning Letter

October 3, 2014

Impurities, particulates, and a lack of communication are among Hospira's recent violations described in a warning letter from FDA.

New Tax Rules May Deter Future Pharma M&A

October 1, 2014

Inversions in the pharmaceutical sector could become less lucrative as a result of new tax laws.

NIH Launches Human Safety Study of Ebola Vaccine Candidate

August 29, 2014

The National Institute of Allergy and Infectious Diseases will begin the first in a series of trials for an Ebola vaccine during the week of Sept. 1.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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